The following applications may have different release dates: RegulatoryOne and Veeva Claims.
The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future Vault releases.
| Description |
Issue No. |
|
In some cases, Vault fails to run the CTMS Transfer Standard Mapping Cleanup job.
|
DEV-698411 |
|
In cases where a document has already been transferred to a target Vault, the source Vault only updates the metadata of the Steady State version of the document on subsequent transfers.
|
DEV-699549 |
|
Vault displays the incorrect error message when attempting to run the Document Quality Control workflow action when there are no deployed models.
|
DEV-717685 |
|
In some cases, Vault will accept invalid entries on a Disclosure record and mark the record Complete.
|
DEV-725800 |
|
In some cases when navigating between sections of a Disclosure record, Vault will validate empty fields.
|
DEV-725869 |
|
In some cases, Vault fails to receive Subject Visits from CDMS.
|
DEV-727763 |
|
In some cases, CTMS Transfer marks inactive Metric lifecycles in the source Vault as active in the target Vault.
|
DEV-727984 |
|
Vault fails to receive transfers from CDMS when Event Groups contain special characters.
|
DEV-728409 |
|
Testing a Trained Model in a sandbox Vault may fail if the model contains a document type which does not exist in the sandbox Vault.
|
DEV-728773 |
|
Vault incorrectly allows access to the Send to Sites user action on documents associated with more than one Study or Site.
|
DEV-730840 |
|
In some cases, Vault opens document links within weekly summary notifications in an incorrect document viewer.
|
DEV-733224 |
|
Vault fails to create new Site Users.
|
DEV-733999 |
|
In some cases, Vault will incorrectly mark incomplete Safety Distributions as being sent, preventing future sending attempts.
|
DEV-735016 |
|
In some cases when the CSV file contains encoding errors, Vault fails to validate the Site Candidate CSV file.
|
DEV-735560 |
|
Vault fails to train models from production when the parent Vault has document types not in the child Vault.
|
DEV-736743 |
|
In some cases in Site Connect, Vault may incorrectly create Site Settings records as Active and Connected for Sites that have pending agreements.
|
DEV-738340 |
|
The lifecycle state of Site Home Access records may be incorrect when the Site Connect invitation job encounters certain scenarios that include required fields on related Person records.
|
DEV-738341 |
|
For connected Study Sites with "email safety when connected" enabled, Vault may display duplicate document rows in a safety distribution grid for safety documents with an email delivery method.
|
DEV-738592 |
|
Vault may incorrectly create study country and site performance metrics for a document type for which the classification does not contain a Study Country or Site.
|
DEV-738666 |
|
In certain cases in Site Connect, the Distribute to Sites action may create a distribution task for a site without a supporting document.
|
DEV-739219 |
|
A user may be unable to transfer documents from SiteVault to a Clinical Operations Vault if there are any custom required date fields.
|
DEV-739325 |
|
In some cases, Vault incorrectly changes the lifecycle state of a Safety Distribution document from In Progress to At Site when the distribution occurs.
|
DEV-739742 |
|
In cases where 5,000 or more users are being migrated to Veeva ID, Vault fails to complete the migration.
|
DEV-740000 |
|
Vault displays the incorrect error message when a user attempts to connect USNs for document exchange without the proper permissions.
|
DEV-740352 |
|
Vault fails to default the Sponsor Template for Site field on Informed Consent Forms to No, resulting in document versions received from Sites incorrectly creating new documents
|
DEV-740420 |
|
When the Site Connect User field is set to Yes via bulk action on Study Personnel records and the action is run a second time, Vault incorrectly creates duplicate records.
|
DEV-740505 |
|
If an active SiteVault Connection is disabled directly rather than disabling an eConsent Study Site Acceptance, non-Vault Owners will not be able to reconnect Study Sites for eConsent.
|
DEV-742374 |
|
In some cases, Vault resets Monitoring Events back to their initial type after the second time they are updated via TMF Transfer.
|
DEV-743014 |
|
In cases where the connection between Clinical Vault and SiteVault is inactivated while there are pending Study Site Acceptance Records, Vault fails to re-establish the connection.
|
DEV-743254 |
| Description |
Issue No. |
|
When a site user runs an FTP export, the Study ID is missing and are also not included in the audit trail.
|
MYVC-20636 |
|
Sponsor Staff are unable to save an eConsent form when it includes a URL that has an ampersand (&) in it. As a workaround, in the URL, replace any ampersand with the following text: &
|
MYVC-23284 |
|
When a sponsor staff member ends UAT in Studio, the status of the ePRO Collection in the sandbox is changed to Deleted and can no longer be used for testing.
|
MYVC-24256 |
|
When a sponsor/CRO staff member upversions an existing collection that has a library survey and then changes the schedule on that survey, the survey is unlocked and becomes study-specific.
|
MYVC-24258 |
|
When a sponsor/CRO staff member creates or updates a study site in the ePRO Vault and the timezone is set to (GMT+00:00) UTC, errors are displayed for site staff and MyVeeva users.
|
MYVC-24553 |
|
When multiple studies are created in quick succession from a ClinOps Connection, sponsor/CRO staff are unable to access Studio. As a workaround, wait a few minutes between updating the Connect to ePRO Vault field on multiple studies.
|
MYVC-24731 |
| Description |
Issue No. |
|
Document reference fields with a "specific" document version reference require component security on the unbound field.
|
DEV-697563 |
|
In some cases, when a user changes the value of a document reference field, Vault may not immediately update the Version field selector with the new document versions.
|
DEV-707923 |
|
Under certain conditions, viewing an object reference field causes a server error.
|
DEV-714046 |
|
In some cases. users may receive a server error when using 4-byte characters in an object field Description or Help Content or in an object record Name.
|
DEV-717308 |
|
In some cases, Vault may erase label values for help controls.
|
DEV-722825 |
|
Under certain conditions, when attempting to create a related record record fails due to missing required fields, users receive a server error rather than an error message that required fields are missing.
|
DEV-723602 |
|
In certain cases, when a user uses the Set Default action to make a different layout than the current one default, both layouts end up marked as the default_layout true instead of just one. This may cause unexpected behavior when viewing a record detail view.
|
DEV-724991 |
|
In some cases, field labels may display split across page breaks in Print Record outputs.
|
DEV-726561 |
|
In some cases, when creating a new object record with a document field, the record may be created with an invalid value in that field.
|
DEV-727083 |
|
In some cases, users may be unable to remove custom lookup fields from a layout rule if a standard controlling field is used as part of a standard or custom layout rule.
|
DEV-728406 |
|
In some cases, on the Details page for an object with grandparent, parent, and child object fields, the display label for the child object shows the grandparent label where the parent label should be.
|
DEV-730641 |
|
Fields configured with field-level security may not display as expected in Print Record outputs.
|
DEV-735803 |
|
From the Validation Rules tab on an object, selecting "Edit" from the Actions menu for a validation rule takes the user to the validation rule detail page instead of the edit page.
|
DEV-736168 |
|
When printing records which contain icons, icon formulas which resolve to null cause an unexpected error.
|
DEV-738549 |
| Description |
Issue No. |
|
Vault may fail to make Display Fields and Filter Fields in the Record Check Interface non-editable and hidden.
|
DEV-702857 |
|
Users may encounter a server error when they attempt to access the `owner_v` field on a Risk Assessment object record.
|
DEV-714144 |
|
Vault may display a banner for an outdated test step when the Executor is updated for multiple steps.
|
DEV-721518 |
|
When all records of the same Study Person or Study Person Responsibility objects fail to transfer via the Study Training-Clinical Operations Connection, Vault produces a generic error insufficient for troubleshooting.
|
DEV-726010 |
|
When a Classroom Training Assignment does not have any active workflows and is accessed from a mobile device, Vault displays the desktop task page to Learners.
|
DEV-726658 |
|
Admins may be unable to modify the status of the `internalexternal__v` field on the CAPA Action object.
|
DEV-728806 |
|
There may be fields missing from the Risk Builder interface or users may encounter an unexpected error.
|
DEV-730929 |
|
Test step cards may blink repeatedly if a user saves a test step or reloads the page.
|
DEV-731299 |
|
In rare cases, Vault may fail to load the Record Check Interface after a user runs a recurrence check.
|
DEV-731892 |
|
Vault displays an unhelpful error message when a user without the proper object permissions attempts to access the Learner Homepage.
|
DEV-732106 |
|
Vault may fail to yield search results on the Visual Navigator landing page.
|
DEV-732355 |
|
Translations may not be available on the Process Navigator interface.
|
DEV-732837 |
|
Vault may fail to automatically update the navigation panel when a user saves a test script and its state transitions from In Authoring to other states.
|
DEV-737923 |
| Description |
Issue No. |
|
In some cases, error messages that display while using the Auditor Profile & Qualification Management feature are only partially translated into the user's language.
|
DEV-696739 |
|
When the Process Hazard Analysis section in the Information panel of the HACCP Flow Diagram refreshes, the Information panel's scrollbar resets to the top regardless of its previous position.
|
DEV-707954 |
|
If multiple PRP records join the same Process Hazard Analysis record with the same CCP Library record, the PRP subsection of the Information panel on the HACCP Flow Diagram does not display all duplicate PRP records.
|
DEV-708228 |
|
If a user loses Read permission for the Hazard Analysis Complete (hazard_analysis_complete__v) field on the HACCP Plan Process Step Group (haccp_plan_process_step_group__v) object while viewing the HACCP Flow Diagram, refreshes the Information panel, and clicks the Hazard Analysis Completeness Check icon, an icon indicating an incomplete hazard analysis status displays on applicable Process Step Groups.
|
DEV-708405 |
|
The question and justification fields in the Categorization of Control Measures subsection of the Information panel on the HACCP Flow Diagram are not spaced appropriately.
|
DEV-708649 |
|
If a user attempts to run the Create HACCP Plan Design from Design action on a HACCP Plan after losing Edit permission for the Language (language__v) or Translation Source (translation_source__v) fields on the HACCP Plan (haccp_plan__v) object, the action fails and Vault displays an error message.
|
DEV-717682 |
|
When selecting CCP Library records to create PRPs or Control Measures for a Process Step on the HACCP Flow Diagram, users see an unexpected error message upon clicking Save in the selection dialog if any of the selected CCP Library records were subsequently deleted after selection.
|
DEV-720089 |
|
In some cases, there are color and color contrast inconsistencies between icons and their backgrounds in the section headers of the Information panel on the HACCP Flow Diagram.
|
DEV-723219 |
|
When an update to field values on a Process Hazard Analysis record triggers a bulk action to delete more than 1,000 associated Process Hazard Analysis - Hazard join records, the CSV file included with the resulting notification contains an unexpected error instead of a message explaining why the bulk deletion failed.
|
DEV-723985 |
|
If a user saves edits to a Process Step directly on the HACCP Flow Diagram while the Information panel is also in Edit mode and then clicks the Edit icon in the General section header of the Information panel, Vault displays a "Section may have unsaved changes" dialog.
|
DEV-725623 |
|
In some cases when a Process Step associated with more than 15 Process Hazard Analyses is selected on the HACCP Flow Diagram and a user then clicks on a Process Step associated with 15 or less Process Hazard Analyses, the “Showing 15/N” indicator text for the previously selected Process Step briefly persists in the Process Hazard Analyses section of the Information panel while the details load for the newly selected Process Step.
|
DEV-726647 |
|
The Categorization of Control Measures subsection of the Information panel displays “All fields are required to be filled in.” helper text when the subsection is in not in Edit mode.
|
DEV-728019 |
|
The Create HACCP Plan Design from Design action fails on HACCP Plans that have at least one (1) Process Hazard Analysis associated with a HACCP Plan Process Step Group.
|
DEV-730191 |
|
Error messages and configuration fields for the Create Proposed Audits user action are not translated into the user’s preferred language.
|
DEV-731419 |
|
If users click on a Control Measure or PRP record in the Process Hazard Analysis section of the Information panel on the HACCP Flow Diagram, the record opens in a new tab instead of a new browser window.
|
DEV-742651 |
| Description |
Issue No. |
|
The submission metadata of invalid content plan items have eCTD4 fields populated and picked up as a reuse target by other content plan items.
|
DEV-700575 |
|
In some cases, publishing logs for CA Submissions include unexpected exceptions related to RIM102.
|
DEV-703766 |
|
Users without object permissions are able to view records in the IDMP Viewer.
|
DEV-715600 |
|
The advance search does not filter out correctly.
|
DEV-715648 |
|
In some cases, the drag and drop popup does not open with all related fields where user doesn't have view permission for the event and activity object.
|
DEV-720042 |
|
When an additional column filter is applied, the Save View As button displays in stead of Save View.
|
DEV-720122 |
|
When a global filter is changed on a saved view, the Save View As button displays in stead of Save View.
|
DEV-720214 |
|
In some cases Active Dossier Items and Active Dossier Item Details are missing in the Active Dossier viewer after collapsing or expanding the section.
|
DEV-721006 |
|
A Content Plan Item with delete operation is shown as replaced in the binder and submission metadata.
|
DEV-721469 |
|
When users select and subsequently update selections for a large number (~500) of Drug Packaging or Product Variant records, the Create and Manage Event Details wizard does not properly filter related Packaging details for selection.
|
DEV-721756 |
|
Publishing fails with an internal error when Vault attempts to merge Submission Content Plan sections for Bosnia submissions.
|
DEV-721937 |
|
FHIR documents display in the IDMP Viewer for users without appropriate permissions, and an attempt to select one results in a blank page.
|
DEV-722035 |
|
Users receive an error when attempting to save a view of extracted Health Authority Question records.
|
DEV-724024 |
|
In some cases, users receive error when running content plan creation and all content plan items are not created.
|
DEV-725625 |
|
When the global filter is changed, the country columns are not refreshed.
|
DEV-727348 |
|
A search is performed when the user refreshes the page without clicking apply.
|
DEV-727580 |
|
When a user creates a multi-sectioned Active Dossier hierarchy and attempts to expand the sections, the page goes blank.
|
DEV-727626 |
|
When a user selects the parent secion from a breadcrumb, the global filter is not refreshed.
|
DEV-727658 |
|
When grab and pan mode is enabled on a Submissions Archive document rendition in the embedded document viewer, scrolling downward on the main body of the page causes the document viewer header to overlap the tab bar.
|
DEV-729918 |
|
When an Active Dossier document’s Language field is blank, the Active Dossier Viewer does not display the Language column in the item’s hovercard.
|
DEV-730724 |
|
When the RIM-PromoMats Vault Connection fails to cascade Content Plan Item activation, Vault produces a User Exception Item with insufficient information for troubleshooting.
|
DEV-731373 |
|
In some cases, users are incorrectly able to advance in the global to local flow of the Create Related Records wizard without populating the Submission Type field.
|
DEV-732301 |
|
Publishing fails for Report Level Content Plan Items where the Report Level Content Plan field is blank. Vault also merges and publishes previously-published documents, even if the document’s Ready for Publishing field is No.
|
DEV-733049 |
|
During on-demand publishing, Vault executes fewer validation rules for index and regional Content Plan Items than for the parent/root Content Plan record.
|
DEV-734084 |
|
In some cases if a Table of Contents of a Content Plan Item does not have the correct Page Number values set on a Publishing Element, the SCP Publish and Merge user action will fail.
|
DEV-734732 |
|
Users without Application > Vault Owner Actions > All Object Record Read in their permission set are unable to generate UDI data.
|
DEV-735521 |
|
In some cases, Active Dossier Item Details fail to create for the same source document in multiple different content plan sections.
|
DEV-738459 |
|
In some cases, Vault displays a Page Not Found error to users attempting to complete the Verify Registration Data workflow task.
|
DEV-740716 |
|
When Submissions Archive Viewer users apply a filter to a text column, the viewer displays duplicate Correspondence sections within the Application section if the Correspondence Vault Library source documents have an associated Submission record.
|
DEV-745775 |
|
When Submissions Archive Viewer users apply a filter to at least one text column and the Regulatory Objective column, the viewer does not display any results.
|
DEV-743727 |
| Description |
Issue No. |
|
Users receive an error to refresh the page when initiating Case workflows.
|
SAF-56246 |
|
Users with the Case Processing security profile are able to edit Cases in the Approved state and they receive an incorrect error message when trying to edit Cases in the Closed state.
|
SAF-56890 |
|
The Narrative Preview field is not immediately populated on Follow-up Cases created from imported Cases.
|
SAF-56982 |
|
If an eSignature page placeholder is located between two root sections in a binder, it moves to the end of the binder upon approval.
|
SAF-57273 |
|
Users receive a server error when navigating to the PSMF Logbook Panel from a PSMF Core Document.
|
SAF-57638 |
|
When the Base Language is set to Japanese, some values in the Message Catalog for the Sender Based Inbound Validations group are not translated.
|
SAF-58258 |
|
When the Product Type field is edited on a Drug History record, Age at Vaccination is not auto-calculated or cleared as expected.
|
SAF-58910 |
|
When Age at Onset is entered manually on an Inbox Item, upon Case promotion, Vault evaluates Expectedness based on age incorrectly.
|
SAF-59554 |
|
If a user does not have Read permission on a CDMS Subject Information object, Vault shows an error message when they try to view the corresponding tab or column in the Add Relevant Subject Information dialog.
|
SAF-59654 |
|
Frequency values entered in decimals on Inbox Items are rounded off to the nearest whole number upon Case promotion.
|
SAF-59830 |
|
In Vaults with Strict Case Locking enabled and Isolation of Blinded Product Information disabled, users can edit the Product (Study) field on Cases with double-blinded studies. When Isolation of Blinded Product Information is enabled, Vault displays an unexpected error message when a user tries to save changes to the field.
|
SAF-59912 |
|
In some cases, fields in the Contacts section are unexpectedly masked on the Case Compare page for a Follow-Up Case.
|
SAF-60279 |
|
The PMDA.E.i.3.1-1 Validation Criteria fails unexpectedly when the Case or Submission has a Special Report Classification of Safety Measure or Research Report.
|
SAF-60327 |
|
In some cases, running the Evaluate Reporting Obligations action on a Localized Case generates unexpected table of contents Submissions on the global Case.
|
SAF-60496 |
|
In some cases when a localized Case already exists, the Re-generate Domestic Case action does not link the localized Case to the localized parent Case.
|
SAF-60848 |
|
Users with the Case Processing security profile with the Transmission Response Object and Transmission Checklist permission sets cannot edit question responses or add questions or sections as expected.
|
SAF-60988 |
|
In some cases when a user navigates to a Case Product from a Case and selects a WHODrug value from the browser, the WHODrug value does not populate on the Case Product.
|
SAF-61029 |
|
In some cases, the Product and Event (LLT) field values are unexpectedly blank on the Case Compare page after a user selects a filter.
|
SAF-61158 |
|
Generated transmission documents for CBER VAERS and FDA E2B R3 fails at schema validation for combination product Cases.
|
SAF-61306 |
|
If a Dictionary object layout includes the Active IMDRF Version field, which is not enabled for the applicable object type, Vault displays a server error when trying to save the layout.
|
SAF-61472 |
|
In some cases when trying to refresh a sandbox Vault, Vault displays an error message that it is unable to create or refresh the sandbox due to configured cloning rules.
|
SAF-61473 |
|
In some cases, Admins cannot navigate between object layout pages using the drop-down.
|
SAF-61715 |
|
Transmission Output Templates with Patient Content Protection set to Mask PII do not populate Exceptions to Patient Content Protection field values on Submissions and Distributions.
|
SAF-61753 |
|
If the Clinical Trials: Isolate Blinded Product Information feature is enabled, users may experience performance issues when updating Case Assessment Result records on Cases with a large number of Assessment records.
|
SAF-61772 |
|
In some cases, users receive an error when merging to an in-flight Case if the Inbox Items were created using the Safety-EDC Vault Connection.
|
SAF-62113 |
|
The Age of Vaccination field does not populate when promoting an Inbox Item to a Case.
|
SAF-62167 |
|
In some cases, Inbox Items generated from the Medical-Safety Connection, Vault does not populate custom unit field values.
|
SAF-62291 |
|
When an unblinded Study Case with multiple products is exported to an E2B file, the values of the G.k.2.3.r.1 Substance / Specified Substance Name data element are mapped incorrectly.
|
SAF-62323 |
|
Transmission Output Templates do not generate multiple submissions to the same agency or multiple distributions to the same partner. If the due date is not less than the rule's Due Date, Vault ignores the applicable Transmission Profile.
|
SAF-62361 |
|
The AE in Jurisdiction Source reporting rule parameter is case-sensitive.
|
SAF-62775 |
|
When a Case is reportable to PMDA but a Japan Localized Case does not exist, the Evaluate Regulatory Conformance action results in unexpected ICH validation errors.
|
SAF-62865 |